VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K222822 ↗

FDA Product Code

BZE

Device Class

Class II

Regulation

21 CFR Part 868.5270

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K253647 Active Cleared 7 May 2026

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  Class II

  FDA 510(k) K221118 Active Cleared 5 Apr 2023

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  Class II

  FDA 510(k) K162821 Active Cleared 23 Jun 2017

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  Class II

  FDA 510(k) K242769 Active Cleared 4 Apr 2025

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  Class II

  FDA 510(k) K222207 Active Cleared 16 May 2023

• Infinity Acute Care System Workstation Critical Care Open recall

  Class II

  FDA 510(k) K093633 Active Cleared 30 Mar 2010

See all devices from Draegerwerk AG & Co. KGaA →